OBJECTIVES: I. Determine the efficacy of picibanil sclerotherapy in children with macrocystic lymphangioma.

Condition	Treatment or Intervention
Lymphatic Diseases Lymphangioma Cardiovascular Abnormalities	Drug: picibanil

PROTOCOL OUTLINE: This is a randomized, multicenter study. Patients are stratified according to prior treatment (no prior treatment vs prior surgical treatment) and geographic area. Patients are randomized to 1 of 2 treatment arms. Arm I (Immediate treatment group): Patients receive an intralesional injection of picibanil with the aid of ultrasonography, transillumination, or fluoroscopy for localization of cysts. Treatment repeats every 6-8 weeks for a total of 4 injections. Arm II (Delayed treatment group): Patients are observed for 24-26 weeks with lesion size measured every 6-8 weeks. At the conclusion of the observation period, patients receive picibanil as in arm I. Patients with life-threatening lymphangiomas receive treatment immediately as in arm I with the option of surgical rescue. Patients are followed at 6 months, 1 year, and 2 years.

Ages Eligible for Study:  6 Months   -   18 Years,  Genders Eligible for Study:  Both

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Diagnosis of macrocystic lymphangioma of the head and/or neck Cystic spaces at least 2.0 mL confirmed by radiographic imaging (MRI or CT) Mixed lymphangiomas (macrocystic and microcystic disease) allowed if macrocystic component comprises at least 50% of the total disease burden
• No mixed hemangioma-lymphangioma lesions
• At least 6 months since prior surgery for lymphangioma
• Patients who require emergency treatment are eligible but not entered into randomization

--Patient Characteristics--

• Hematopoietic: No clinically significant hematologic disease No hemodynamic instability
• Hepatic: No clinically significant hepatic disorder
• Renal: No clinically significant renal disease No personal or family history of post-streptococcal glomerulonephritis
• Cardiovascular: No personal or family history of rheumatic heart disease
• Pulmonary: No respiratory failure

Other:

• Not pregnant or nursing
• Negative pregnancy test
• No history of allergy to penicillin
• No concurrent temperature of 100.5 degrees or greater
• No active upper respiratory infection
• No personal or family history of obsessive-compulsive or tic disorders
• No personal or family history of PANDA (pediatric autoimmune neuro- psychiatric disorder associated with streptococcal infections)
• No history of hypersensitivity to iodine, Omnipaque, or gadolinium (if fluoroscopy is considered necessary)
• No history of poor health (including congenital disorders, chronic diseases, or immunologic dysfunction)

Alabama
      Children's Hospital of Alabama, Birmingham,  Alabama,  35233,  United States; Recruiting
California
      Children's Associated Medical Group, San Diego,  California,  92123,  United States; Recruiting
Colorado
      Children's Hospital of Denver, Denver,  Colorado,  80218,  United States; Recruiting
Iowa
      University of Iowa Hospitals and Clinics, Iowa City,  Iowa,  52242,  United States; Recruiting
Minnesota
      Children's Hospitals and Clinics - Minneapolis, Minneapolis,  Minnesota,  55404,  United States; Recruiting
Texas
      Texas Pediatric Otolaryngology Center, Houston,  Texas,  77030,  United States; Recruiting
Virginia
      Children's Hospital of the Kings Daughter, Norfolk,  Virginia,  23507,  United States; Recruiting
Wisconsin
      Children's Hospital of Wisconsin, Milwaukee,  Wisconsin,  53201,  United States; Recruiting
      University of Wisconsin Hospital and Clinics, Madison,  Wisconsin,  53792-0001,  United States; Recruiting

Study chairs or principal investigators

Richard J Smith,  Study Chair,  University of Iowa   

Study ID Numbers:  199/15706; UIHC-FDR001774
Record last reviewed:  February 2001
Record first received:  February 2, 2001
ClinicalTrials.gov Identifier:  NCT00010452
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2004-11-09